Alcami Presenting Environmental Monitoring Webinar on November 18

by Alcami Corporation, on Oct 26, 2020 8:58:36 AM

Join Alcami on November 18

We're launching our new environmental monitoring & cleanroom service offering with an interactive webinar on Wednesday, November 18 from 11:00 am to 12:00 pm EST. Join environmental monitoring expert, Katie Kovalevich, to learn about our newest capability.

"I've serviced over 150 cleanrooms and am thrilled to problem solve and share what I know on this critical need for so many industries," said Katie Kovalevich, Laboratory & Environmental Monitoring Sales & Marketing Manager. "If you have questions prior to the webinar, you can also schedule a meeting now."

Topics: Events News & Events Cleanroom Services Environmental Monitoring

Alcami Attending CPhI Festival of Pharma

by Alcami Corporation, on Oct 2, 2020 9:31:34 AM

Schedule to meet with Alcami at Festival of Pharma


CPhI Festival of Pharma is a virtual gathering launched to bring the global pharma industry together online, the Festival of Pharma fills the gap left by in-person events at a time when travel and gatherings are off the cards to let you connect with companies and clients from around the world.

Topics: Events News & Events

Alcami Continues to Execute Strategic Plan to Focus Its Platform with Sterling Pharma Solutions’ Acquisition of API Facility in US

by Alcami Corporation, on Sep 30, 2020 11:58:11 AM

Global contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions, has announced its acquisition of Alcami’s Germantown, Wisconsin facility in the US.

The new facility will further bolster Sterling’s US presence and will provide additional capacity for customer API development and manufacturing projects, specifically those with complex and hazardous requirements. The Germantown facility houses state-of-the-art cGMP development, scale-up and manufacturing facilities. Germantown has specialist expertise in handling technologies including plant-scale hydrogenation and cryogenic reactions.

Topics: News & Events Blogs

Alcami Hosting Virtual Open House of New Sterile Fill-Finish Development & Manufacturing Facility

by Alcami Corporation, on Sep 29, 2020 2:27:27 PM

Join Alcami on Friday October 9

We're kicking off the opening of our new formulation and sterile fill-finish facility with a digital open house on October 9 from 1:00 to 2:00 pm EDT. Join key members of Alcami's operational and commercial leadership teams to learn about our newest facility featuring four filling lines with isolator and flexible manufacturing technology.

Topics: Events News & Events Formulations Parenteral Manufacturing

Food Studies 101

by Alcami Corporation, on Sep 9, 2020 11:34:40 AM

Alcami’s scientists have substantial experience designing and executing food studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms.

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients. Geriatric, pediatric, and patients suffering from gastroesophageal reflux disease are often administered pharmaceuticals mixed with food or liquids due to difficulty swallowing tablets or capsules. For immediate release, enteric coated, modified release, or extended release dosage forms, a food study is required to evaluate whether the alternate route of administration impacts the therapeutic dose.

Topics: News & Events Blogs Food Studies

Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK

by Alcami Corporation, on Aug 26, 2020 10:39:10 AM

Alcami, a US-based contract development and manufacturing organization, announced today that it is providing commercial manufacturing services for Trevena’s newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in adults for the management of acute pain severe enough to require an intravenous opioid analgesic. Alcami has provided development and clinical support for this program for several years leading up to Trevena’s approval from the U.S. Food and Drug Administration.

Topics: News & Events Blogs

Alcami RTP Expansion Nears Completion

by Alcami Corporation, on Jul 28, 2020 10:03:04 AM

MORRISVILLE, N.C., July 28, 2020 -- Alcami, a US-based contract development and manufacturing organization (CDMO), is pleased to announce that its 56,000 square foot expansion in Research Triangle Park (RTP), reached the first milestone of operational readiness with the start of GMP laboratory testing this month. This brand-new site with state-of-the-art design and controls became part of Alcami when TriPharm Services was acquired in January 2020. 20,000 square feet will be dedicated to microbiology, formulation development, and analytical chemistry services. Specific investment has been made to offer industry-leading environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase 1 of the manufacturing facility in Q4 2020, which will bring the first two filling suites online and the next major milestone.

Topics: News & Events Blogs

505(b)(2): What You Need to Know

by Andrea Young, on Jul 20, 2020 9:00:54 AM

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). A 505(b)(2) application is a hybrid between the FDA's traditional NDA and an abbreviated new drug application (ANDA). These submission types were made possible in 1984 by the adoption of the Hatch-Waxman Act. The act was created to allow for generic competition and increased innovation in the pharmaceutical arena. A true generic or ANDA demonstrates that the drug is identical to an already approved product based on bioequivalence data and chemical equivalence.

Topics: News & Events Regulatory Compliance Blogs 505(b)(2)

Roundtable Discussion with Pharma's Almanac: Greatest Drug Molecules to Impact Society & the Pharmaceutical Industry

by Madhu Shaik, on Jul 7, 2020 3:34:06 PM

Q: What two or three drug molecules do you identify as having had the greatest impact on society? What about on the pharmaceutical industry?

Over the last century, several groundbreaking inventions in drug discovery have contributed to a remarkable increase in life expectancy. Against this backdrop, it is difficult to identify three drugs having had the greatest impact on society. I’ve identified three that changed the course of medicine.

Insulin: The discovery of insulin revolutionized both the therapy and prognosis of diabetes. This is one of the most studied diseases in the history of medicine, dating back to Egyptian medical texts in 1552 BC. Ever since the isolation of insulin from pancreas tissue in 1923, numerous efforts were made to produce fully synthetic insulin, from rDNA human insulin in 1978 to various insulin analogs in 1996, aimed at optimizing the insulin absorption, distribution, metabolism, and elimination. The dream someday is for a needle-free delivery of insulin by oral route.

Topics: News & Events Editorials Blogs

Reducing Risk with Abuse‑Deterrent Formulations

by Angela Moore, on Jun 16, 2020 12:44:01 PM

Excerpted from Pharmaceutical Technology's editorial titled, "Reducing Risk with Abuse‑Deterrent Formulations."

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.

Possibly the most publicized and well-documented form of drug misuse and abuse has been that of opioids—prescription pain-relief medicines. The opioid crisis, which has impacted the global health community for several years, has paved the way for increased demand in abuse-deterrent formulations.

Abuse-deterrent formulations essentially have the potential to provide an effective way of reducing the capabilities of an end-user to abuse or misuse a medical therapy, while maintaining the drug’s clinical benefit. To explore the topic of abuse-deterrent formulations in more detail, Pharmaceutical Technology spoke with Angela Moore, scientist, Analytical Development, Alcami.

Topics: News & Events Abuse-Deterrence Editorials Blogs

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